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State presses e-cigarette case

FDA’s decision to stay ban doesn’t change Minnesota trial plans

Laura Brown//July 13, 2022

Close-up of a woman exhaling smoke while holding a JUUL pen e-cigarette

A woman exhales while vaping from a Juul pen e-cigarette in Vancouver, Washington, April 16, 2019. (AP file photo)

State presses e-cigarette case

FDA’s decision to stay ban doesn’t change Minnesota trial plans

Laura Brown//July 13, 2022

JUUL Labs — which markets e-cigarettes — has temporarily escaped an FDA ban on the sale of its products in the United States. Despite this, Minnesota remains committed to taking the company to trial, the initiation of which began almost three years ago.

E-cigarettes entered the market as a “safer” alternative to traditional cigarettes or even a way to stop smoking, allowing users to inhale a nicotine aerosol. According to Johns Hopkins, research has shown that while e-cigarettes appear to be less harmful than smoking because of fewer toxic chemicals, their use still can still cause profound health consequences. Use of e-cigarettes has caused thousands of cases of people being hospitalized for vaping lung disease, some resulting in death.

What is concerning is that nearly one in five of these cases involved someone under the age of 18. Before e-cigarettes, teen smoking levels were extremely low. Now, more than one in five high school students use e-cigarettes, according to the United States Surgeon General. In 2019, the Minnesota Department of Health found that more than half of 11th-graders had vaped within the last month. Many e-cigarettes are flavored, which has driven sales among youth. Many are flavored like drinks, candy, and other treats that kids enjoy.

In 2019, Attorney General Keith Ellison announced that Minnesota would be suing JUUL, arguing violation of many consumer protection laws, creation of a public nuisance, and breach of duty of reasonable care. “I’m bringing a lawsuit against JUUL today because it has created a public nuisance that is centered around deceiving, addicting, and harming our young people,” Ellison stated at the time of the lawsuit. Minnesota seeks the end of youth marketing of e-cigarettes, monetary relief, and civil penalties.

JUUL is facing thousands of lawsuits across the country, including lawsuits from 13 states. In its first state settlement back in June 2021, JUUL agreed to pay North Carolina $40 million. In November 2021, it agreed to pay Arizona $14.5 million. In April 2022, JUUL settled with Washington state for $22.5 million.

One June 23, 2022, the Biden administration and the FDA ordered JUUL to remove the JUUL device and four types of JUULpods from the market due to JUUL’s failure to comply with regulations regarding menthol and nicotine in the products. According to an FDA press release, it argued that that JUUL’s studies “raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”

This prevented those products from being sold or distributed. “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commission Robert M. Califf, M.D. stated.

Just one day later, the U.S. Court of Appeals for the D.C. Circuit stayed the FDA’s order to ban sales, granting JUUL’s request. The court wrote that, “The purpose of this administrative stay is to give the court sufficient opportunity to consider [JUUL’s] forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion.” It gave the FDA until July 7, 2022, to respond to JUUL’s motion. Then, on July 5, 2022, the FDA announced it had administratively stayed the marketing denial order, claiming that the FDA “has determined that there are scientific issues unique to the JUUL application that warrant additional review.” However, the FDA was clear that staying of the marketing denial order was not equivalent to rescinding it altogether. “The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products,” the FDA maintained.

What ultimately happens there will influence Minnesota’s actions; but, for now, the plan is to move on for a trial set to commence on March 27, 2023, in Hennepin County District Court. “While we monitor the impact of the FDA decision and the D.C. Circuit’s review, those events will not impede the State of Minnesota’s litigation against Juul and Altria. We continue to prepare for trial,” Ellison said. “The FDA decision only reinforces the State’s allegations in our complaint against JUUL and Altria, challenging the risks that the two companies created for the State’s youth and the harms they inflicted.”

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